MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) IDENTITY ADX XL DR; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number	5386
Medical Device Problem Code	Pacemaker Found in Back-Up Mode (1440)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	01/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented during clinical follow-up.Upon interrogation, it was noted that the pacemaker was found in backup mode.No interventions were performed.The patient was in stable condition.
Event or Problem Description
Additional information received noted that the pacemaker was explanted.The patient's condition was unknown.
Event or Problem Description
Additional information received noted that the pacemaker was explanted.The patient's condition was unknown.
Additional Manufacturer Narrative
The reported event of backup mode was confirmed.As received, a device was returned for analysis in backup mode with battery voltage at end of life (eol).Analysis noted unknown backup operation at above elective replacement indicator(eri) levels.A new battery was connected, product code was reloaded and programmed to nominal settings.Electrical and mechanical analysis performed and indicated normal device functionality.The backup condition could not be reproduced.The cause of the reported event could not be determined.
Additional Manufacturer Narrative
The reported event of back-up mode was confirmed.As received, the pacer was returned in backup mode with battery voltage at end of life (eol).A new battery was connected, product code was reloaded and programmed to nominal settings.Backup condition could not be reproduced.No other anomalies were observed.

• Brand Name: IDENTITY ADX XL DR
• Common Device Name: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 16302095
• Report Number: 2017865-2023-05065
• Device Sequence Number: 6086220
• Product Code: DXY
• UDI-Device Identifier: 05414734006903
• UDI-Public: 05414734006903
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 04/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2008
• Device Model Number: 5386
• Device Catalogue Number: 5386
• Device Lot Number: 0002121201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2023
• Supplement Date Received by Manufacturer: 01/16/2023; 08/18/2023; 08/17/2023; 02/14/2024; 03/12/2024; 04/03/2024
• Initial Report FDA Received Date: 02/05/2023
• Supplement Report FDA Received Date: 08/14/2023; 08/18/2023; 08/24/2023; 02/29/2024; 03/12/2024; 04/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2006
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PASSIVE TIN; TENDRIL SDX
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White